StrokeNCT02942875
Motor Recovery of the Severely Impaired Paretic Upper Limb After Mirror Therapy in Sub-acute Stroke
A study testing mirror therapy in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Our study aims at investigating the effect of intensive mirror therapy on the motor recovery of severely impaired paretic arm at subacute stroke. Read more about this study
- Who is it for?
- Ages 35 to 100 years
- Conditions the study is for
- Stroke
- What is being tested?
- mirror therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteHong Kong
- Study dates
- Sep 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 35 years or older
- first stroke within the first month after stroke onset;
- has upper limb paresis contralateral to the side of cerebral hemisphere with stroke;
- Presence of active movements (at least flicker of movement in gravity free position, but not able to accomplish full range of motion against gravity) at any one joint of shoulder, elbow and hand of hemiplegic arm, and Motricity Index less than 47.
- Able to follow instructions
Who cannot join
- has visual impairment not correctable by corrective lens;
- has cognitive impairment (Mini-Mental State Examination score < 22/30)
- has comprehension or expression aphasia;
- Presence of visuospatial neglect
- has premorbid neurological or musculoskeletal conditions that affect movements in the upper limbs
Trial locations and contacts
1 site in 1 country.
About this study
Our study aims at investigating the effect of intensive mirror therapy on the motor recovery of severely impaired paretic arm at subacute stroke.
Read the detailed description
It was reported that upper limb hemiparesis happened in 80% of stroke patients and only 20% regained full arm function 6 months post stroke. The paretic upper arm accounted for 50% of the variance in functional limitation after stroke. Early and intensive upper limb intervention can promote motor recovery of paretic arm and is associated with better upper limb functional outcomes on 6 month post stroke. Mirror therapy (MT) is one of the potential approach in enhancing motor recovery of paretic arm after stroke. However, the effect of intensive MT on the motor recovery of severely impaired paretic arm after stroke has not been investigated. Knowledge on the effect of intensive MT on motor recovery can enhance formulation of effective and efficiency treatment protocol in stroke rehabilitation. Therefore, our study aims at investigating the effect of intensive MT on the motor recovery of severely impaired paretic arm of patients at subacute phase of stroke.
Stroke patients admitted to Haven of Hope Hospital will be screened according to inclusion and exclusion criteria. Eligible subjects will consent and be randomized into two groups: MT group- subjects will have daily two 30-min sessions of standardized bilateral upper limbs exercise with presence of mirror, 5 days per week for 4 consecutive weeks. During MT, a mirror is placed in the patient's mid-sagittal plane, with the reflecting surface facing the non-paretic upper limb so that the reflected image of this non-paretic limb would be perceived as the paretic upper limb. Subjects are instructed to watch at the movements of the reflected image of the non-paretic limbs and at the same time, the paretic upper limb should imitate the observed movements and be synchronized with those of the good side. Standardized bilateral upper limbs exercise (4 sets of 30 repetitions of shoulder, elbow, wrist and fingers movements) will be carried out within 30 min per session. Control group subjects will receive same daily two sessions of standardized bilateral upper limbs exercise without mirror, 5 days per week for 4 consecutive weeks. Motor functions of paretic arm of subjects measured by Fugl-Meyer Assessment (motor domain) and Wolf Motor Function Test will be assessed by independent assessor who is blinded to the group allocation of subjects before and after the 4-week intervention. Baseline comparison between the two groups was tested with independent t-test and the difference among and between groups after intervention will be tested by repeated measures ANOVA with level of significant at 0.05.
- Conditions
- Stroke
- Being tested
- mirror therapy, control therapy
- Keywords
- upper limb, mirror therapy, rehabilitation, subacute
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirror therapyOther
During MT, subjects will sit in front of a table on which a mirror will be placed vertically in the space ipsilateral to the paretic upper limb with its reflective surface facing the unaffected upper limb. The subjects are required to look at the mirror to observe the reflective image of the unaffected arm from shoulder to the hand, while it is performing certain designated movements. At the same time, the affected arm will be required to follow the unaffected arm to practice the same movements.
The upper limbs movements during the 30-min MT session are open and close of grasp; wrist flexion and extension; forearm supination and pronation; elbow flexion and extension; shoulder flexion and extension. A total of 120 repetitions for each action will be practiced.
control therapyOther
Control group subjects undergo the same bilateral upper limbs exercise protocol without mirror
| Study group | Role | What they receive |
|---|---|---|
| Mirror therapy group | Experimental | MT group subjects will attend training sessions of bilateral upper limb exercise daily in the presence of the mirror. Receives: Other: mirror therapy |
| Control therapy group | Active comparator | Control group subjects will undergo the same training sessions of bilateral upper limb exercise daily without mirror. Receives: Other: control therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment arm score
Measured: 4 weeks
Secondary outcomes (1)
Wolf Motor Function Test
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startSep 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHAN Wing Chiu, The Hong Kong Polytechnic University
- Investigators
- Wing Chiu Chan, MSc, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942875
- Sponsor's protocol ID
- HSEARS20140613004
- Status last verified
- Oct 2016
- First submitted
- 21 Oct 2016
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kwakkel G, van Peppen R, Wagenaar RC, Wood Dauphinee S, Richards C, Ashburn A, Miller K, Lincoln N, Partridge C, Wellwood I, Langhorne P. Effects of augmented exercise therapy time after stroke: a meta-analysis. Stroke. 2004 Nov;35(11):2529-39. doi: 10.1161/01.STR.0000143153.76460.7d. Epub 2004 Oct 7.
PubMed 15472114Michielsen ME, Selles RW, van der Geest JN, Eckhardt M, Yavuzer G, Stam HJ, Smits M, Ribbers GM, Bussmann JB. Motor recovery and cortical reorganization after mirror therapy in chronic stroke patients: a phase II randomized controlled trial. Neurorehabil Neural Repair. 2011 Mar-Apr;25(3):223-33. doi: 10.1177/1545968310385127. Epub 2010 Nov 4.
PubMed 21051765Altschuler EL, Wisdom SB, Stone L, Foster C, Galasko D, Llewellyn DM, Ramachandran VS. Rehabilitation of hemiparesis after stroke with a mirror. Lancet. 1999 Jun 12;353(9169):2035-6. doi: 10.1016/s0140-6736(99)00920-4. No abstract available.
PubMed 10376620Barker WH, Mullooly JP. Stroke in a defined elderly population, 1967-1985. A less lethal and disabling but no less common disease. Stroke. 1997 Feb;28(2):284-90. doi: 10.1161/01.str.28.2.284.
PubMed 9040676Buccino G, Binkofski F, Fink GR, Fadiga L, Fogassi L, Gallese V, Seitz RJ, Zilles K, Rizzolatti G, Freund HJ. Action observation activates premotor and parietal areas in a somatotopic manner: an fMRI study. Eur J Neurosci. 2001 Jan;13(2):400-4.
PubMed 11168545Cacchio A, De Blasis E, De Blasis V, Santilli V, Spacca G. Mirror therapy in complex regional pain syndrome type 1 of the upper limb in stroke patients. Neurorehabil Neural Repair. 2009 Oct;23(8):792-9. doi: 10.1177/1545968309335977. Epub 2009 May 22.
PubMed 19465507Dohle C, Pullen J, Nakaten A, Kust J, Rietz C, Karbe H. Mirror therapy promotes recovery from severe hemiparesis: a randomized controlled trial. Neurorehabil Neural Repair. 2009 Mar-Apr;23(3):209-17. doi: 10.1177/1545968308324786. Epub 2008 Dec 12.
PubMed 19074686Ertelt D, Small S, Solodkin A, Dettmers C, McNamara A, Binkofski F, Buccino G. Action observation has a positive impact on rehabilitation of motor deficits after stroke. Neuroimage. 2007;36 Suppl 2:T164-73. doi: 10.1016/j.neuroimage.2007.03.043. Epub 2007 Mar 31.
PubMed 17499164Ezendam D, Bongers RM, Jannink MJ. Systematic review of the effectiveness of mirror therapy in upper extremity function. Disabil Rehabil. 2009;31(26):2135-49. doi: 10.3109/09638280902887768.
PubMed 19903124Feys H, De Weerdt W, Nuyens G, van de Winckel A, Selz B, Kiekens C. Predicting motor recovery of the upper limb after stroke rehabilitation: value of a clinical examination. Physiother Res Int. 2000;5(1):1-18. doi: 10.1002/pri.180.
PubMed 10785907Han C, Wang Q, Meng PP, Qi MZ. Effects of intensity of arm training on hemiplegic upper extremity motor recovery in stroke patients: a randomized controlled trial. Clin Rehabil. 2013 Jan;27(1):75-81. doi: 10.1177/0269215512447223. Epub 2012 Jul 16.
PubMed 22801472Hsieh YW, Wu CY, Liao WW, Lin KC, Wu KY, Lee CY. Effects of treatment intensity in upper limb robot-assisted therapy for chronic stroke: a pilot randomized controlled trial. Neurorehabil Neural Repair. 2011 Jul-Aug;25(6):503-11. doi: 10.1177/1545968310394871. Epub 2011 Mar 24.
PubMed 21436390Invernizzi M, Negrini S, Carda S, Lanzotti L, Cisari C, Baricich A. The value of adding mirror therapy for upper limb motor recovery of subacute stroke patients: a randomized controlled trial. Eur J Phys Rehabil Med. 2013 Jun;49(3):311-7. Epub 2013 Mar 13.
PubMed 23480975Kwakkel G, Kollen BJ, van der Grond J, Prevo AJ. Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke. Stroke. 2003 Sep;34(9):2181-6. doi: 10.1161/01.STR.0000087172.16305.CD. Epub 2003 Aug 7.
PubMed 12907818Lamont K, Chin M, Kogan M. Mirror box therapy: seeing is believing. Explore (NY). 2011 Nov-Dec;7(6):369-72. doi: 10.1016/j.explore.2011.08.002.
PubMed 22051561
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Recovery of the Severely Impaired Paretic Upper Limb After Mirror Therapy in Sub-acute Stroke
- ClinicalTrials.gov ID
- NCT02942875
- Acronym / sponsor ID
- HSEARS20140613004
- Conditions
- Stroke
- Keywords
- upper limb, mirror therapy, rehabilitation, subacute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our study aims at investigating the effect of intensive mirror therapy on the motor recovery of severely impaired paretic arm at subacute stroke.
Detailed description
It was reported that upper limb hemiparesis happened in 80% of stroke patients and only 20% regained full arm function 6 months post stroke. The paretic upper arm accounted for 50% of the variance in functional limitation after stroke. Early and intensive upper limb intervention can promote motor recovery of paretic arm and is associated with better upper limb functional outcomes on 6 month post stroke. Mirror therapy (MT) is one of the potential approach in enhancing motor recovery of paretic arm after stroke. However, the effect of intensive MT on the motor recovery of severely impaired paretic arm after stroke has not been investigated. Knowledge on the effect of intensive MT on motor recovery can enhance formulation of effective and efficiency treatment protocol in stroke rehabilitation. Therefore, our study aims at investigating the effect of intensive MT on the motor recovery of severely impaired paretic arm of patients at subacute phase of stroke.
Stroke patients admitted to Haven of Hope Hospital will be screened according to inclusion and exclusion criteria. Eligible subjects will consent and be randomized into two groups: MT group- subjects will have daily two 30-min sessions of standardized bilateral upper limbs exercise with presence of mirror, 5 days per week for 4 consecutive weeks. During MT, a mirror is placed in the patient's mid-sagittal plane, with the reflecting surface facing the non-paretic upper limb so that the reflected image of this non-paretic limb would be perceived as the paretic upper limb. Subjects are instructed to watch at the movements of the reflected image of the non-paretic limbs and at the same time, the paretic upper limb should imitate the observed movements and be synchronized with those of the good side. Standardized bilateral upper limbs exercise (4 sets of 30 repetitions of shoulder, elbow, wrist and fingers movements) will be carried out within 30 min per session. Control group subjects will receive same daily two sessions of standardized bilateral upper limbs exercise without mirror, 5 days per week for 4 consecutive weeks. Motor functions of paretic arm of subjects measured by Fugl-Meyer Assessment (motor domain) and Wolf Motor Function Test will be assessed by independent assessor who is blinded to the group allocation of subjects before and after the 4-week intervention. Baseline comparison between the two groups was tested with independent t-test and the difference among and between groups after intervention will be tested by repeated measures ANOVA with level of significant at 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirror therapy group | Experimental | Other: mirror therapyMT group subjects will attend training sessions of bilateral upper limb exercise daily in the presence of the mirror. |
| Control therapy group | Active comparator | Other: control therapyControl group subjects will undergo the same training sessions of bilateral upper limb exercise daily without mirror. |
Who may qualify
- Ages
- 35 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 35 years or older
- first stroke within the first month after stroke onset;
- has upper limb paresis contralateral to the side of cerebral hemisphere with stroke;
- Presence of active movements (at least flicker of movement in gravity free position, but not able to accomplish full range of motion against gravity) at any one joint of shoulder, elbow and hand of hemiplegic arm, and Motricity Index less than 47.
- Able to follow instructions
Key exclusion criteria (5 listed)
- has visual impairment not correctable by corrective lens;
- has cognitive impairment (Mini-Mental State Examination score < 22/30)
- has comprehension or expression aphasia;
- Presence of visuospatial neglect
- has premorbid neurological or musculoskeletal conditions that affect movements in the upper limbs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mirror therapyDuring MT, subjects will sit in front of a table on which a mirror will be placed vertically in the space ipsilateral to the paretic upper limb with its reflective surface facing the unaffected upper limb. The subjects are required to look at the mirror to observe the reflective image of the unaffected arm from shoulder to the hand, while it is performing certain designated movements. At the same time, the affected arm will be required to follow the unaffected arm to practice the same movements. The upper limbs movements during the 30-min MT session are open and close of grasp; wrist flexion and extension; forearm supination and pronation; elbow flexion and extension; shoulder flexion and extension. A total of 120 repetitions for each action will be practiced. | Other | Mirror therapy group |
| control therapyControl group subjects undergo the same bilateral upper limbs exercise protocol without mirror | Other | Control therapy group |
Primary outcome
Fugl-Meyer Assessment arm score
Time frame: 4 weeks
1 secondary outcome
Wolf Motor Function Test
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
- Background: PubMed 15472114Kwakkel G, van Peppen R, Wagenaar RC, Wood Dauphinee S, Richards C, Ashburn A, Miller K, Lincoln N, Partridge C, Wellwood I, Langhorne P. Effects of augmented exercise therapy time after stroke: a meta-analysis. Stroke. 2004 Nov;35(11):2529-39. doi: 10.1161/01.STR.0000143153.76460.7d. Epub 2004 Oct 7.
- Background: PubMed 21051765Michielsen ME, Selles RW, van der Geest JN, Eckhardt M, Yavuzer G, Stam HJ, Smits M, Ribbers GM, Bussmann JB. Motor recovery and cortical reorganization after mirror therapy in chronic stroke patients: a phase II randomized controlled trial. Neurorehabil Neural Repair. 2011 Mar-Apr;25(3):223-33. doi: 10.1177/1545968310385127. Epub 2010 Nov 4.
- Results publication: PubMed 10376620Altschuler EL, Wisdom SB, Stone L, Foster C, Galasko D, Llewellyn DM, Ramachandran VS. Rehabilitation of hemiparesis after stroke with a mirror. Lancet. 1999 Jun 12;353(9169):2035-6. doi: 10.1016/s0140-6736(99)00920-4. No abstract available.
- Results publication: PubMed 9040676Barker WH, Mullooly JP. Stroke in a defined elderly population, 1967-1985. A less lethal and disabling but no less common disease. Stroke. 1997 Feb;28(2):284-90. doi: 10.1161/01.str.28.2.284.
- Results publication: PubMed 11168545Buccino G, Binkofski F, Fink GR, Fadiga L, Fogassi L, Gallese V, Seitz RJ, Zilles K, Rizzolatti G, Freund HJ. Action observation activates premotor and parietal areas in a somatotopic manner: an fMRI study. Eur J Neurosci. 2001 Jan;13(2):400-4.
- Results publication: PubMed 19465507Cacchio A, De Blasis E, De Blasis V, Santilli V, Spacca G. Mirror therapy in complex regional pain syndrome type 1 of the upper limb in stroke patients. Neurorehabil Neural Repair. 2009 Oct;23(8):792-9. doi: 10.1177/1545968309335977. Epub 2009 May 22.
- Results publication: PubMed 19074686Dohle C, Pullen J, Nakaten A, Kust J, Rietz C, Karbe H. Mirror therapy promotes recovery from severe hemiparesis: a randomized controlled trial. Neurorehabil Neural Repair. 2009 Mar-Apr;23(3):209-17. doi: 10.1177/1545968308324786. Epub 2008 Dec 12.
- Results publication: PubMed 17499164Ertelt D, Small S, Solodkin A, Dettmers C, McNamara A, Binkofski F, Buccino G. Action observation has a positive impact on rehabilitation of motor deficits after stroke. Neuroimage. 2007;36 Suppl 2:T164-73. doi: 10.1016/j.neuroimage.2007.03.043. Epub 2007 Mar 31.
- Results publication: PubMed 19903124Ezendam D, Bongers RM, Jannink MJ. Systematic review of the effectiveness of mirror therapy in upper extremity function. Disabil Rehabil. 2009;31(26):2135-49. doi: 10.3109/09638280902887768.
- Results publication: PubMed 10785907Feys H, De Weerdt W, Nuyens G, van de Winckel A, Selz B, Kiekens C. Predicting motor recovery of the upper limb after stroke rehabilitation: value of a clinical examination. Physiother Res Int. 2000;5(1):1-18. doi: 10.1002/pri.180.
- Results publication: PubMed 22801472Han C, Wang Q, Meng PP, Qi MZ. Effects of intensity of arm training on hemiplegic upper extremity motor recovery in stroke patients: a randomized controlled trial. Clin Rehabil. 2013 Jan;27(1):75-81. doi: 10.1177/0269215512447223. Epub 2012 Jul 16.
- Results publication: PubMed 21436390Hsieh YW, Wu CY, Liao WW, Lin KC, Wu KY, Lee CY. Effects of treatment intensity in upper limb robot-assisted therapy for chronic stroke: a pilot randomized controlled trial. Neurorehabil Neural Repair. 2011 Jul-Aug;25(6):503-11. doi: 10.1177/1545968310394871. Epub 2011 Mar 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wing Chiu Chan, MSc principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mirror therapy in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment arm score (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02942875, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2016.